Physical ActivityMAINTAIN-IINCT02946060
The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II
A study testing Audiobooks and Tempo-pace synchronized playlists in people with Physical Activity, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial summary
This study (MAINTAIN -II) aims to examine the effect of audio playlists [with or without Rhythmic Auditory Stimulation (RAS)] on the weekly volume of physical activity. Participants will be randomized into 3 Interventions: Control (standard, usual care), Audiobook, or Tempo-pace Synchronized Playlists (TSP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Audiobooks and Tempo-pace synchronized playlists
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known cardiovascular disease who are participating in and have been declared medically stable for outpatient cardiac rehabilitation
- Patients must be at least 18 years of age
- Patients must have received at least one exercise prescription that includes consistent walking and/or running (no high interval training or stationary machines)
Who cannot join
- Participants unable to wear the iPod device or activity monitoring device due to medical or non-medical issues
- Participants with significant communication impairments
- Participants currently enrolled in another intervention study
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cardiac Rehabilitation and Prevention Program
Toronto, Ontario, M4G 2V6
About this study
This study (MAINTAIN -II) aims to examine the effect of audio playlists [with or without Rhythmic Auditory Stimulation (RAS)] on the weekly volume of physical activity. Participants will be randomized into 3 Interventions: Control (standard, usual care), Audiobook, or Tempo-pace Synchronized Playlists (TSP). The investigators also aim to explore the effects of these interventions on mood, perceived exertion and dissociative attention among patients participating in cardiac rehabilitation.
Read the detailed description
Physical activity is associated with a 35% decrease in cardiovascular mortality - a direct result of exercise on the vasculature and an indirect result of exercise lowering CVD risk factors such as lipids and blood pressure. With physical inactivity being one of the major independent risk factors for CVD, structured exercise cardiac rehabilitation programs have been implemented to encourage adherence to physical activity among patients with cardiac related issues. Clinical trial evidence has demonstrated irrefutable mortality and morbidity benefits associated with cardiac rehabilitation especially among patients with established CVD. The mechanisms for improved outcomes are likely multifactorial, including improved preventative self-management, physical activity volume, and cardiopulmonary fitness. Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by behavioural attrition, with programmatic drop out and suboptimal physical activity adherence patterns that mirror the broader healthy population who are not enrolled in cardiac rehabilitation.
Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by attrition rates of up to 50% post rehabilitation. The goal would therefore be to introduce a co-intervention that encourages long-term exercise adherence for maximal health improvements in cardiac rehabilitation populations, which might also have broader applicability to other non-cardiac rehab populations.
The prior study, The Music Activity INTervention for Adherence Improvement through Neurological entrainment (MAINTAIN -1), examined the use of Tempo Synchronized Playlists (TSP) on improving exercise adherence within the cardiac rehabilitation program. Weekly volumes of physical activity were compared between groups assigned to 3 interventions: control group receiving Usual Care, TSP, and Tempo-pace Synchronized Playlists with Rhythmic Auditory Stimulation (RAS). Rhythmic Auditory Stimulation is a neurological rehabilitation technique used to accentuate tempo-pace synchrony. The group assigned to the TSP intervention demonstrated a significantly higher volume in weekly exercise than the usual care control group. Furthermore, the group randomized to TSP with RAS partook in twice the amount of weekly physical activity than the TSP group without RAS. Our prior study had several limitations including small sample size and an inability to examine the mechanisms by which RAS tempo-based audio-playlist synchronization mediated increases in physical activity.
The objective of this current study is to build on our previous research by examining the reproducibility of efficacy and exploring the mechanisms such as mood, perceived exertion and dissociative attention, by which the preference-based tempo-pace synchronized playlists improve exercise adherence among patients participating in cardiac rehabilitation. Participants will be randomized into 3 Interventions: Usual Care, Audiobooks, and TSP, that will be assigned during months 2 and 3 of the program. The Usual Care group will feature a nested design by which half patients will randomized to receive a silent track during month 2, and the other half will receive white noise. This sequence will be reversed during month 3. Within the TSP intervention, 2 nested designs will be tested. The first will test RAS with non-RAS. Half of the patients will be randomized to receive TSP with RAS during month 2 of the study, while the other half will receive TSP without RAS during month 2. The sequence will be reversed in month 3. The second will determine the effect on training by comparing 'active' vs. 'passive'. Within the active group, participants will be trained on how to exercise with the music. The passive group will not be trained.
Cardiac Rehabilitation provides an ideal test-case program by which to examine music co-interventions, as it mirrors the behavioural attrition experienced in other structured or unstructured exercise activities. Additionally, a music tempo-pace synchronization strategy is appropriate in such a setting as it helps to regulate the exercise pace prescribed to each patient by the program.
- Conditions
- Physical Activity
- Being tested
- Audiobooks, Tempo-pace synchronized playlists, Usual Care
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AudiobooksOther
iPods with audiobooks
Tempo-pace synchronized playlistsOther
Playlists with or without RAS
Usual CareOther
iPods containing either a silent track or white noise
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Sham comparator | Participants in this intervention will receive the minimal standard of care provided at the Cardiac Rehabilitation and Prevention Program at Toronto Rehabilitation Institute. Participants will receive an iPod with a silent track or white noise. Receives: Other: Usual Care |
| Audiobooks | Active comparator | Participants in this arm will receive iPods with Audiobooks based on their preferred genres. Receives: Other: Audiobooks |
| Tempo-pace Synchronized Playlists | Experimental | Participants in this arm will receive audio playlists synchronized to their exercise pace. Rhythmic enhancements will be added to the playlists during either month 2 or month 3 of the study. Receives: Other: Tempo-pace synchronized playlists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average volume of physical activity per week per intervention
The activity monitor will be worn each week for 12 weeks. Average minutes of physical activity per week will be compared between groups.
Measured: 12 weeks
Secondary outcomes (9)
Affect measured by Feeling Scale
During participant's biweekly exercise session, scores on the Feeling Scale will be recorded per lap.
Measured: Biweekly for the duration of 12 weeks
Arousal measured by Score on Felt Arousal
During participants biweekly exercise session, scores on the Felt Arousal Scale will be recorded per lap
Measured: Biweekly for the duration of 12 weeks
Perceived Exertion measured by Rate of Perceived Exertion Scale
During participants biweekly exercise session, scores on the Rate of Perceived Exertion Scale (RPE) will be recorded per lap.
Measured: Biweekly for the duration of 12 weeks
Dissociative Attention measured by the Tammen's Scale
During participants biweekly exercise session, scores on the Tammen's scale will be recorded per lap.
Measured: Biweekly for the duration of 12 weeks
Focus measured by the Focus Questionnaire
During participants' biweekly exercise session, focus on the audio in the headphones will be recorded at the end of the exercise.
Measured: Biweekly for the duration of 12 weeks
Pacing of Exercise
Number of steps in one minute will be counted during exercise session.
Measured: Biweekly for the duration of 12 weeks
Lap time
Time taken to complete one lap will be recorded for each biweekly exercise session.
Measured: Biweekly for the duration of 12 weeks
Playcounts
Number of plays of the audio file per week will be recorded
Measured: 8 week duration
Future Hospitalizations and/or Mortality
Participants will be tracked longitudinally throughout health service encounters including physician visits, hospitalizations, and mortality.
Measured: Within 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Dr. David Alter, Toronto Rehabilitation Institute
- Investigators
- Dr. David Alter, MD,PhD,FRCPC, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946060
- Sponsor's protocol ID
- 15-9839
- Acronym
- MAINTAIN-II
- Status last verified
- Apr 2020
- First submitted
- 19 Sep 2016
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alter DA, Wijeysundera HC, Franklin B, Austin PC, Chong A, Oh PI, Tu JV, Stukel TA. Obesity, lifestyle risk-factors, and health service outcomes among healthy middle-aged adults in Canada. BMC Health Serv Res. 2012 Aug 4;12:238. doi: 10.1186/1472-6963-12-238.
PubMed 22863333Alter DA, Zagorski B, Marzolini S, Forhan M, Oh PI. On-site programmatic attendance to cardiac rehabilitation and the healthy-adherer effect. Eur J Prev Cardiol. 2015 Oct;22(10):1232-46. doi: 10.1177/2047487314544084. Epub 2014 Jul 30.
PubMed 25079239Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Brewer, BW., Van Raalte, JL, & Linder, DE. (1996). Attentional Focus and Endurance Performance. Applied Research in Coaching and Athletics Annual. 11:1-14.
Brownley KA, McMurray RG, Hackney AC. Effects of music on physiological and affective responses to graded treadmill exercise in trained and untrained runners. Int J Psychophysiol. 1995 Apr;19(3):193-201. doi: 10.1016/0167-8760(95)00007-f.
PubMed 7558986Chen JL, Zatorre RJ, Penhune VB. Interactions between auditory and dorsal premotor cortex during synchronization to musical rhythms. Neuroimage. 2006 Oct 1;32(4):1771-81. doi: 10.1016/j.neuroimage.2006.04.207. Epub 2006 Jun 14.
PubMed 16777432Davies P, Taylor F, Beswick A, Wise F, Moxham T, Rees K, Ebrahim S. Promoting patient uptake and adherence in cardiac rehabilitation. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007131. doi: 10.1002/14651858.CD007131.pub2.
PubMed 20614453Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16.
PubMed 21576654Hardy, CJ., & Rejeski, WJ. (1989). Not What, but How One Feels: the Measurement of Affect During Exercise. J. Sport Exerc Psychol. 11:304-317
Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
PubMed 21735386Kendzierski D, DeCarlo KJ. Physical Activity Enjoyment Scale: Two validation studies. Journal of Sport & Exercise Psychology. 1991;13(1):50-64.
Measuring Enjoyment of Physical Activity in Children: Validation of the Physical Activity Enjoyment Scale. J Appl Sport Psychol. 2009 Jan 1;21(S1):S116-S129. doi: 10.1080/10413200802593612.
PubMed 20209028Nakamura PM, Pereira G, Papini CB, Nakamura FY, Kokubun E. Effects of preferred and nonpreferred music on continuous cycling exercise performance. Percept Mot Skills. 2010 Feb;110(1):257-64. doi: 10.2466/PMS.110.1.257-264.
PubMed 20391890Nocon M, Hiemann T, Muller-Riemenschneider F, Thalau F, Roll S, Willich SN. Association of physical activity with all-cause and cardiovascular mortality: a systematic review and meta-analysis. Eur J Cardiovasc Prev Rehabil. 2008 Jun;15(3):239-46. doi: 10.1097/HJR.0b013e3282f55e09.
PubMed 18525377Pinch, TJ., & Bijsterveld, K. (2012). The Oxford Handbook of Sound Studies. New York: Oxford University Press.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Music Activity INTervention for Adherence Improvement Through Neurological Entrainment - II
- ClinicalTrials.gov ID
- NCT02946060
- Acronym / sponsor ID
- MAINTAIN-II / 15-9839
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study (MAINTAIN -II) aims to examine the effect of audio playlists [with or without Rhythmic Auditory Stimulation (RAS)] on the weekly volume of physical activity. Participants will be randomized into 3 Interventions: Control (standard, usual care), Audiobook, or Tempo-pace Synchronized Playlists (TSP). The investigators also aim to explore the effects of these interventions on mood, perceived exertion and dissociative attention among patients participating in cardiac rehabilitation.
Detailed description
Physical activity is associated with a 35% decrease in cardiovascular mortality - a direct result of exercise on the vasculature and an indirect result of exercise lowering CVD risk factors such as lipids and blood pressure. With physical inactivity being one of the major independent risk factors for CVD, structured exercise cardiac rehabilitation programs have been implemented to encourage adherence to physical activity among patients with cardiac related issues. Clinical trial evidence has demonstrated irrefutable mortality and morbidity benefits associated with cardiac rehabilitation especially among patients with established CVD. The mechanisms for improved outcomes are likely multifactorial, including improved preventative self-management, physical activity volume, and cardiopulmonary fitness. Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by behavioural attrition, with programmatic drop out and suboptimal physical activity adherence patterns that mirror the broader healthy population who are not enrolled in cardiac rehabilitation.
Unfortunately the real-world outcome benefits associated with cardiac rehabilitation are undermined by attrition rates of up to 50% post rehabilitation. The goal would therefore be to introduce a co-intervention that encourages long-term exercise adherence for maximal health improvements in cardiac rehabilitation populations, which might also have broader applicability to other non-cardiac rehab populations.
The prior study, The Music Activity INTervention for Adherence Improvement through Neurological entrainment (MAINTAIN -1), examined the use of Tempo Synchronized Playlists (TSP) on improving exercise adherence within the cardiac rehabilitation program. Weekly volumes of physical activity were compared between groups assigned to 3 interventions: control group receiving Usual Care, TSP, and Tempo-pace Synchronized Playlists with Rhythmic Auditory Stimulation (RAS). Rhythmic Auditory Stimulation is a neurological rehabilitation technique used to accentuate tempo-pace synchrony. The group assigned to the TSP intervention demonstrated a significantly higher volume in weekly exercise than the usual care control group. Furthermore, the group randomized to TSP with RAS partook in twice the amount of weekly physical activity than the TSP group without RAS. Our prior study had several limitations including small sample size and an inability to examine the mechanisms by which RAS tempo-based audio-playlist synchronization mediated increases in physical activity.
The objective of this current study is to build on our previous research by examining the reproducibility of efficacy and exploring the mechanisms such as mood, perceived exertion and dissociative attention, by which the preference-based tempo-pace synchronized playlists improve exercise adherence among patients participating in cardiac rehabilitation. Participants will be randomized into 3 Interventions: Usual Care, Audiobooks, and TSP, that will be assigned during months 2 and 3 of the program. The Usual Care group will feature a nested design by which half patients will randomized to receive a silent track during month 2, and the other half will receive white noise. This sequence will be reversed during month 3. Within the TSP intervention, 2 nested designs will be tested. The first will test RAS with non-RAS. Half of the patients will be randomized to receive TSP with RAS during month 2 of the study, while the other half will receive TSP without RAS during month 2. The sequence will be reversed in month 3. The second will determine the effect on training by comparing 'active' vs. 'passive'. Within the active group, participants will be trained on how to exercise with the music. The passive group will not be trained.
Cardiac Rehabilitation provides an ideal test-case program by which to examine music co-interventions, as it mirrors the behavioural attrition experienced in other structured or unstructured exercise activities. Additionally, a music tempo-pace synchronization strategy is appropriate in such a setting as it helps to regulate the exercise pace prescribed to each patient by the program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Sham comparator | Other: Usual CareParticipants in this intervention will receive the minimal standard of care provided at the Cardiac Rehabilitation and Prevention Program at Toronto Rehabilitation Institute. Participants will receive an iPod with a silent track or white noise. |
| Audiobooks | Active comparator | Other: AudiobooksParticipants in this arm will receive iPods with Audiobooks based on their preferred genres. |
| Tempo-pace Synchronized Playlists | Experimental | Other: Tempo-pace synchronized playlistsParticipants in this arm will receive audio playlists synchronized to their exercise pace. Rhythmic enhancements will be added to the playlists during either month 2 or month 3 of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with known cardiovascular disease who are participating in and have been declared medically stable for outpatient cardiac rehabilitation
- Patients must be at least 18 years of age
- Patients must have received at least one exercise prescription that includes consistent walking and/or running (no high interval training or stationary machines)
Key exclusion criteria (3 listed)
- Participants unable to wear the iPod device or activity monitoring device due to medical or non-medical issues
- Participants with significant communication impairments
- Participants currently enrolled in another intervention study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AudiobooksiPods with audiobooks | Other | Audiobooks |
| Tempo-pace synchronized playlistsPlaylists with or without RAS | Other | Tempo-pace Synchronized Playlists |
| Usual CareiPods containing either a silent track or white noise | Other | Usual Care |
Primary outcome
Average volume of physical activity per week per intervention
Time frame: 12 weeks
The activity monitor will be worn each week for 12 weeks. Average minutes of physical activity per week will be compared between groups.
9 secondary outcomes
Affect measured by Feeling Scale
Time frame: Biweekly for the duration of 12 weeks
Arousal measured by Score on Felt Arousal
Time frame: Biweekly for the duration of 12 weeks
Perceived Exertion measured by Rate of Perceived Exertion Scale
Time frame: Biweekly for the duration of 12 weeks
Dissociative Attention measured by the Tammen's Scale
Time frame: Biweekly for the duration of 12 weeks
Focus measured by the Focus Questionnaire
Time frame: Biweekly for the duration of 12 weeks
Pacing of Exercise
Time frame: Biweekly for the duration of 12 weeks
Lap time
Time frame: Biweekly for the duration of 12 weeks
Playcounts
Time frame: 8 week duration
Future Hospitalizations and/or Mortality
Time frame: Within 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Background: PubMed 22863333Alter DA, Wijeysundera HC, Franklin B, Austin PC, Chong A, Oh PI, Tu JV, Stukel TA. Obesity, lifestyle risk-factors, and health service outcomes among healthy middle-aged adults in Canada. BMC Health Serv Res. 2012 Aug 4;12:238. doi: 10.1186/1472-6963-12-238.
- Background: PubMed 25079239Alter DA, Zagorski B, Marzolini S, Forhan M, Oh PI. On-site programmatic attendance to cardiac rehabilitation and the healthy-adherer effect. Eur J Prev Cardiol. 2015 Oct;22(10):1232-46. doi: 10.1177/2047487314544084. Epub 2014 Jul 30.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- BackgroundBrewer, BW., Van Raalte, JL, & Linder, DE. (1996). Attentional Focus and Endurance Performance. Applied Research in Coaching and Athletics Annual. 11:1-14.
- Background: PubMed 7558986Brownley KA, McMurray RG, Hackney AC. Effects of music on physiological and affective responses to graded treadmill exercise in trained and untrained runners. Int J Psychophysiol. 1995 Apr;19(3):193-201. doi: 10.1016/0167-8760(95)00007-f.
- Background: PubMed 16777432Chen JL, Zatorre RJ, Penhune VB. Interactions between auditory and dorsal premotor cortex during synchronization to musical rhythms. Neuroimage. 2006 Oct 1;32(4):1771-81. doi: 10.1016/j.neuroimage.2006.04.207. Epub 2006 Jun 14.
- Background: PubMed 20614453Davies P, Taylor F, Beswick A, Wise F, Moxham T, Rees K, Ebrahim S. Promoting patient uptake and adherence in cardiac rehabilitation. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007131. doi: 10.1002/14651858.CD007131.pub2.
- Background: PubMed 21576654Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16.
- BackgroundHardy, CJ., & Rejeski, WJ. (1989). Not What, but How One Feels: the Measurement of Affect During Exercise. J. Sport Exerc Psychol. 11:304-317
- Background: PubMed 21735386Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
- BackgroundKendzierski D, DeCarlo KJ. Physical Activity Enjoyment Scale: Two validation studies. Journal of Sport & Exercise Psychology. 1991;13(1):50-64.
- Background: PubMed 20209028Measuring Enjoyment of Physical Activity in Children: Validation of the Physical Activity Enjoyment Scale. J Appl Sport Psychol. 2009 Jan 1;21(S1):S116-S129. doi: 10.1080/10413200802593612.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. David Alter, MD,PhD,FRCPC principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiobooks and Tempo-pace synchronized playlists in people with Physical Activity, run by Toronto Rehabilitation Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average volume of physical activity per week per intervention (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946060, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020; AzTrials last refreshed its copy on 6 Nov 2026.